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news.Pro-Pharmaceuticals is seeking FDA approval for a new formulation of irinotecan to be co-administered with Davanat, as a functional excipient, to treat cancer.
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Irinotecan is a generic chemotherapy agent, marketed in the US as Camptosar. In preclinical studies, Davanat has demonstrated it significantly improves irinotecan activity in the tumor as measured by tumor shrinkage and reduced toxicity, according to Pro-Pharmaceuticals.
The company is using FDA rules which allow faster approval of new formulations of previously approved therapeutics.
“Our goal is to get our lead compound, Davanat to market with multiple chemotherapy drugs,” said David Platt, president and CEO of Pro-Pharmaceuticals.
“We submitted preclinical data to the FDA that demonstrates Davanat improves Irinotecan efficacy on tumor and toxicology data. In other preclinical studies, Davanat also improved FDA-approved chemotherapeutics, such as 5-FU, Oxaliplatin, Cisplatin, Avastin, Taxol and Doxorubicin.”